PACKAGE LEAFLET: INFORMATION FOR THE USER

^j^FOSRENOI! 750 mg oral powder

^j^FOSRENOI! 1000 mg oral powder

lanthanum

Read this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

In this leaflet:

1.    What Fosrenol is and what it is used for

2.    Before you take Fosrenol

3.    How to take Fosrenol

4.    Possible side effects

5.    How to store Fosrenol

6.    Further information

1.    What FOSRENOL is and what it is used for

Fosrenol is used to lower the phosphate level in the blood of patients with chronic kidney disease.

Patients who have kidneys that do not work properly are not able to control the level of phosphate in the blood. The amount of phosphate in the blood then rises (your doctor may call this hyperphosphataemia).

Fosrenol is a medicine which reduces the body's absorption of phosphate from food by binding with it in your digestive tract. Phosphate which has bonded to Fosrenol cannot be absorbed through the intestinal wall.

2.    Before you take FOSRENOL

Do not take Fosrenol

•    if you are allergic (hypersensitive) to lanthanum carbonate hydrate or any of the other ingredients of Fosrenol.

•    if you have too little phosphate in your blood (hypophosphataemia).

Take special care with Fosrenol

If you know that you have or have had any of the following conditions, you should discuss this with your doctor before using Fosrenol:

•    stomach ulcer;

•    ulcerative colitis;

•    Crohn’s disease;

•    blockage of the bowel;

•    reduced liver or kidney function.

If you have reduced kidney function your doctor may decide to check the level of calcium in your blood from time to time. If you have too little calcium, you may then be given extra calcium.

If you have previously had abdominal surgery, or infection or inflammation of the abdomen/bowel (peritonitis) inform your doctor.

If you need to have an x-ray, please inform your doctor that you are taking Fosrenol as it may affect the results.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Taking other medicines

Fosrenol can affect how certain medicines are absorbed from your digestive tract. If you are taking chloroquine (for rheumatism and malaria), ketoconazole (for fungal infections), tetracycline or doxycycline antibiotics they should not be taken within 2 hours before or after taking Fosrenol.

It is not recommended that you take oral floxacin antibiotics (including ciprofloxacin) within 2 hours before or 4 hours after taking Fosrenol.

If you are taking levothyroxine (for an underactive thyroid) it should not be taken within 2 hours before or after taking Fosrenol. Your doctor may want to monitor the levels of thyroid-stimulating hormone (TSH) in your blood more closely.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Fosrenol with food and drink

Fosrenol should be taken with or immediately after food.

Fosrenol oral powder is intended to be mixed with soft food (e.g. applesauce or other similar food product) and then swallowed. Additional fluid is not necessary.

Pregnancy and breast-feeding

Fosrenol should not be taken during pregnancy. If you are, or could be pregnant, talk to your doctor before taking Fosrenol.

As it is not known whether the medicine can be transferred to a child in breast-milk, you should not breast-feed whilst taking Fosrenol. If you are breast-feeding, ask your doctor or pharmacist for advice before taking any medicines.

Driving and using machines

Dizziness and vertigo (a feeling of dizziness or “spinning”) are uncommon side effects reported by patients taking Fosrenol. If you experience these side effects it may affect your ability to drive or operate machinery.

3. How to take FOSRENOL

Always take Fosrenol exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

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You should take Fosrenol with or immediately after food. Fosrenol oral powder is intended to be mixed with soft food (e.g. applesauce or other similar food product) and then swallowed. Additional fluid is not necessary.

Do not open the sachet until ready to use. Mix all of the contents of the sachet into 1-2 spoonfuls of soft food, taking care to see that the entire dose is mixed with the food. Ensure that the oral powder/food mixture is eaten immediately (within 15 minutes). Never store any oral powder/food mixture for use at a later time.

Your doctor will tell you how many sachets of oral powder you must take with each meal (your daily dose will be divided between meals). The number of sachets that you take will depend on:

•    Your diet (the amount of phosphate in the food you eat)

•    Your blood phosphate level

Before starting on Fosrenol oral powder, your doctor may have used Fosrenol chewable tablets to find the correct dose. Fosrenol chewable tablets are available in a number of strengths allowing for smaller increases in dose. The starting dose of chewable tablets is usually 250mg, three times a day with meals. Your dose of oral powder is likely to be 750 or 1000mg, three times a day with meals. Every 2-3 weeks your doctor will check the level of phosphate in your blood and may increase your dose until the level of phosphate in your blood is acceptable and regularly thereafter.

Fosrenol works by binding phosphate from the food in your gut. It is very important to take Fosrenol at every meal. If you change your diet, contact your doctor as you may need to take extra Fosrenol. Your doctor will tell you what to do in this case.

If you take more Fosrenol than you should

If you take too much Fosrenol contact your doctor to assess the risk and obtain advice. Symptoms of overdose may be nausea and headaches.

If you forget to take Fosrenol

It is important to take Fosrenol with every meal.

If you forget to take your Fosrenol, then take the next dose with your next meal. Do not take a double dose to make up for forgotten individual doses.

sweating; taste disturbance and increased white blood cell count.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store FOSRENOL

Keep out of the reach and sight of children.

This medicinal product does not require any special storage conditions.

Do not use Fosrenol after the expiry date which is stated on the carton and the sachets after EXR The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment

4. Possible side effects

Like all medicines, Fosrenol can cause side effects, although not everybody gets them.

Side effects such as nausea and vomiting are more likely if you take Fosrenol before your meal. You should always take it during or immediately after your food.

Very Common side effects (affects more than 1 user in 10):

•    Nausea, vomiting, diarrhoea, stomach pain, headache, itching, rash

Common side effects (affects 1 to 10 users in 100):

•    Constipation, heartburn, flatulence

•    Hypocalcaemia (too little calcium in your blood) is also a common side effect; the symptoms of which can include tingling in the hands and feet, muscle and abdominal cramps or spasms of the facial and feet muscles.

Please inform your doctor if you experience constipation. This can be an early symptom of a blockage in your intestine.

Uncommon side effects (affects 1 to 10 users in 1000):

•    Tiredness; feeling of discomfort; chest pain, weakness; swollen hands and feet; body pain; dizziness; vertigo; belching; inflammation of the stomach and intestines (gastroenteritis); indigestion; irritable bowel syndrome; dry mouth; tooth disorders; inflammation of the gullet or mouth; loose stools; increases in certain liver enzymes, parathyroid hormone; aluminium, calcium and glucose in the blood; increased or reduced phosphate level in the blood; thirst; weight decrease; joint pain; muscle pain; weakness and thinning of the bones (osteoporosis); lack of and increased appetite; inflammation of the larynx; loss of hair; increased

6. Further Information

What Fosrenol contains

•    Each sachet contains 750mg lanthanum (as lanthanum carbonate hydrate).

•    Each sachet contains 1000mg lanthanum (as lanthanum carbonate hydrate)

•    The other ingredients are dextrates (hydrated), colloidal anhydrous silica and magnesium stearate.

What Fosrenol looks like and contents of the pack

This medicinal product is presented as a white to off-white oral powder in a sachet.

The sachets are supplied in a carton of 90 sachets. (Outer carton contains 9 cartons of 10 sachets).

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder is:

Shire Pharmaceutical Contracts Ltd., Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, UK.

The manufacturer is:

Catalent Pharma Solutions, Steinbeisstrasse 2, D-73614 Schorndorf, Germany

Shire Pharmaceutical Contracts Ltd., Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, UK.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Shire Pharmaceutical Contracts Ltd., Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, UK. Tel: 0800 055 6614

This medicinal product is authorised in the Member States of the EEA under the following names:

This leaflet was last approved in: 03/2012

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